The EU Veterinary Medicinal Products Regulation (2019/6) became applicable in January 2022, bringing new requirements and practices for marketing authorisation holders of veterinary medicines. The current Regulation affects, for example, the management, grouping and classification of variations and utilisation of the Union Product Database (UPD) for veterinary medicines. As regards pharmacovigilance, the Regulation introduced a requirement for a more structured pharmacovigilance system and an integrated quality system.
In our webinar you will learn about the main changes and requirements brought about by the Veterinary Medicinal Products Regulation. The first part of the webinar will discuss variation management. We will give you concrete examples of variations, as well as an overview of the QRD 9 template update and the related guidelines. We will also go through a general checklist on variation management.
In the second part of the webinar, we will focus on pharmacovigilance and discuss the relationship between pharmacovigilance systems and the related quality measures.
The webinar is aimed at veterinary companies with pharmaceutical products on the European market or planning to expand into the European market, as well as anyone working with veterinary medicines, such as professionals in the fields of marketing authorisations, pharmacovigilance and quality assurance.
Why participate?
- Gain a comprehensive overview of variation management and timelines
- Get tips on the best practices for QRD 9 template updates
- Learn more about the requirements for pharmacovigilance systems of veterinary medicines as well as the related quality assurance activities
The webinar recording is available for viewing immediately after you order it.
Speakers
Elina Krannila
Senior Regulatory Affairs Expert
“I’m a senior RA expert and have been working at Medfiles since 2011. I’m part of the Medfiles Veterinary Medicines Team, handling regulatory tasks related to marketing authorisations (MA) of veterinary medicines. Our team of experienced specialists works daily with veterinary MA applications and maintenance tasks which mainly concern EU vet products approved through the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national (NP) procedures. We are well versed in veterinary legislation and the applicable regulatory guidance, such as the EU Veterinary Medicinal Products Regulation, UK VMD guidance and the US FDA guidance.”
Satu Kujala
Head of Pharmacovigilance
“I have worked at Medfiles since 1999, and during this time, some 20 years with post-marketing safety of veterinary medicines. Acting as a Qualified Person for Pharmacovigilance of human medicines for over 16 years has given me a thorough understanding of the quality requirements of pharmacovigilance systems. I also act as an auditor at Medfiles.”
Saana Lamminjoki
Drug Safety Expert
“I joined the Medfiles Pharmacovigilance Team in 2021 and have since then been daily involved with veterinary pharmacovigilance activities. My master’s degree in general toxicology has given me a strong foundation for working with a wide range of safety tasks across the pharmaceutical industry. With our extensive experience of implementing the requirements of the current Regulation and the veterinary good pharmacovigilance practices into our everyday work, our team has gained a deep understanding of how to best integrate quality aspects in our pharmacovigilance activities.”
